Spina bifida (myelomeningocele) is a complex birth defect in which a portion of the spinal cord is not fully developed. The overlying bones and skin are incompletely formed and the underdeveloped area of the spinal cord is exposed on the surface of the back. Spina bifida defects are closed soon after birth to prevent further damage to the spinal cord and nerves. The Management of Myelomeningocele Study (MOMS) is a research study comparing two approaches to the treatment of babies with spina bifida: surgery before birth (prenatal surgery) and the standard closure, surgery after birth (postnatal surgery).

Fetal surgery to close spina bifida defect prior to 26 weeks of gestation with delivery by C-Section at approximately 37 weeks of gestation.

Procedure: Prenatal Myelomeningocele Repair Surgery

Fetal surgery to repair spina bifida defect performed prior to 26 weeks of gestation with delivery by C-section at approximately 37 weeks of gestation.

Active Comparator: 2

Standard postnatal closure of the spina bifida defect when the baby is medically stable, usually within 48 hours of birth by C-section.

Procedure: Postnatal Myelomeningocele Repair Surgery

Standard postnatal surgical closure of the spina bifida defect

Detailed Description:

Since 1997, more than 200 fetuses have had in utero closure of myelomeningocele by open maternal-fetal surgery. Preliminary clinical evidence suggests that this procedure reduces the incidence of shunt-dependent hydrocephalus and restores the cerebellum and brainstem to more normal configuration. However, clinical results of prenatal surgery for myelomeningocele are based on comparisons with historical controls and examine only efficacy, not safety. MOMS will determine if intrauterine repair of fetal myelomeningocele at 19 to 25 weeks of gestation improves outcomes as compared to standard postnatal repair. Outcomes assessed include death, the need for ventricular decompressive shunting by one year of life and neurologic function at 30 months of age.

Two hundred women, whose fetuses have spina bifida, will be enrolled in the study and randomized to have either prenatal surgery or postnatal surgery. After a central screening process which includes a medical record review, all women will have an extensive baseline evaluation that will include ultrasound, MRI, physical exam, social work evaluation, psychological screening, and education about spina bifida and prenatal surgery.

For women who are eligible following the central screening process, all screening, surgery and follow-up visits will be performed at one of three MOMS Centers. The mother, if eligible, and her support person will travel (at the expense of the study) to the MOMS Center for screening and randomization.

Women assigned to have prenatal surgery will be scheduled for surgery within 1 to 3 days after they are randomized. They will stay near the MOMS Center until they deliver. Women in the postnatal group will travel back to their assigned MOMS Center to deliver. Both groups will deliver their babies by C-section around the 37th week of their pregnancies. Babies born to women in the postnatal surgery group will have their spina bifida defects closed when they are medically stable, usually within 48 hours of birth.

Children and their parents will return to their assigned MOMS Center at 1 year and 2 ½ years of age for follow-up evaluation. Motor function, developmental progress, and bladder, kidney, and brain development will be assessed. The children will be asked to return for an additional follow-up visit (MOMS2) between the ages of 5 to 8. This follow-up is to determine whether children who received the surgery before birth have better health and mental outcomes and live more independently and function more safely and appropriately in daily life than those who received the surgery after birth.

Eligibility

Ages Eligible for Study:

18 Years and older

Genders Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

Criteria

Inclusion Criteria

Pregnant women carrying a fetus diagnosed with myelomeningocele

Myelomeningocele lesion that starts no higher than T1 and no lower than S1 with hindbrain herniation present

Gestational age at randomization of 19 weeks 0 days to 25 weeks 6 days

Normal karyotype

Singleton pregnancy

United States resident

Able to travel to study site for study evaluation, procedures, and visits (if randomized to prenatal surgery, must stay near center until delivery)

Support person to travel and stay with participant

Exclusion Criteria

Maternal insulin-dependent pregestational diabetes

Short or incompetent cervix or cervical cerclage

Placenta previa

Body mass index of 35 or more

Previous spontaneous delivery prior to 37 weeks

Maternal HIV, Hepatitis-B or Hepatitis-C status positive

Uterine anomaly

Maternal medical condition which is a contraindication to surgery or general anesthesia

Other fetal anomaly

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00060606